BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇧🇪 Belgium

    Ontex and other proprietary names

    K Number: K162746 · Decision Mar 3, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    93
    Same Product Code
    188
    Applicant Total
    6
    Review Days
    154

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    Basic Information

    Device Name
    Ontex and other proprietary names
    K Number
    K162746
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5470
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ontex Bvba
    Date Received
    September 30, 2016
    Decision Date
    March 3, 2017
    Product Code
    HEB
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HEB Tampon, Menstrual, Unscented

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    Other Clearances by Ontex Bvba

    K Number Device Name
    K191666 Unscented W long plastic and cardboard applicator tampons
    K142786 Ontex Unscented Tampons with Colored Plastic Applicators
    K132595 ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONS
    K132208 ONTEX AND OTHERS PROPRIETARY NAMES
    K122603 ONTEX AND OTHER PROPRIETARY NAMES